Negative Control

The controls are designed to monitor and validate the performance of drugs of abuse detection methods at levels established by SAMHSA, CAP/AACC and many state programs. The controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents. They should be treated as any Unknown specimen while following the specific protocol of the assay being used. This product is intended to be used by health care professionals as an integral part of good laboratory practices.

Each bottle contains stabilized human based urine. Positive controls have been spiked with authentic reference drug standards and or appropriate metabolites. Negative controls are certified negative by a combination of immunoassay, GC/MS and or LC/MS for the constituents listed on our target streets.

Required Amounts For All In One Cups:Two(2) 5ml jars per test

Required Amounts For Dip Tests: One(1) 5ml jar

Storage & Stability:

Unopened:

The controls are stable until the expiration date when stored at -10 to -2C and protected from light.

The controls are stable until the expiration date when stored at 2-8C, however, no stability claims can be made for Oxazepam as it may deteriorate over time when stored refrigerated.

After Opening:

The controls are stable for six months or until the expiration date, whichever comes first, when stored at -10 to -2C. (Controls can be aliquoted and frozen)

The controls are stable for 31 days or until the expiration date, whichever comes first, when stored tightly capped at 2-8C.

Thaw controls as needed; allow to come to room temperature followed by gentle swirling before use.

Procedure:

Allow controls to come to room temperature followed by gentle swirling or inversion before use. DO NOT SHAKE. Pipette an appropriate aliquot of Detectabuse control urine as required by the drugs of abuse test device or screening method.

Expected Results:

The positive control must test positive on the drugs of abuse test device or screening method. The
negative control must test negative. Biochemical Diagnostics will (upon request), supply assay values derived from our contract assay laboratories and customer base on a particular lot of control material

Detectabuse Controls, THC Stability:

Detectabuse controls are stable for the length of time under the storage conditions stated in the package insert. In spite of this fact, under certain conditions, there may be observed a gradual decline in THC levels, over time, from continuous use of a single bottle of control material. This drop in THC values may occur from any THC sample (i.e. calibrators, controls, and samples). The apparent loss of THC most often occurs from handling and not from product instability.

It is well known that THC-COOH binds to surfaces, especially certain plastics. In order to minimize this adsorption loss we recommend the following when handling any sample (including Detectabuse controls) which may contain THC:

Preferably, use glass pipettes or pour controls into sample cups. As an alternate, pipettes with disposable plastic tips may be used. Soft plastic transfer pipettes should be avoided.

Do not rinse the pipette back and forth into the sample.

Sample volume to surface area ratio should be as high as possible (i.e. when transferring, sample containers should be filled as much as possible with sample). Avoid rough surface plastic containers.

When pipetting, immerse the pipette tip as little as possible into the sample solution.

Do not return any unused material back into the original sample.These same guidelines should also be followed when aliquoting a control (or sample) for future use.

Precautions:

For In Vitro Diagnostic Use Only. Please read the entire package insert before using the controls.
Please use the same safety precautions you would use for processing any "unknown urine sample containing potentially infectious biological material. Protect product from exposure to direct sunlight. Contains sodium azide: To prevent formation of explosive metalazides dispose of waste by flushing with copious amounts of water or according to local governing regulations.
Do not use beyond the expiration date.

Limitations of Procedure:

This control is meant to be used to validate the performance of immunoassay drug screening methods. Consult test manufacturers instructions when using this product; changes in reagents, sample requirement, or methodology may effect test results. Although target values are provided with the Detectabuse liquid controls, each laboratory should run these controls as unknowns in order to establish in-house assay values for them. This product is not meant to be used as a standard or calibrator.

Detectabuse Controls, Oxazepam Stability:

Oxazepam has known stability problems in urine stored refrigerated, and to a lesser degree, frozen. Our experience indicates that Oxazepam will not deteriorate more than 10% of target level for at least one year when stored frozen at -20C. Further deteriorations may occur beyond this period although Oxazepam ordinarily tests positive throughout the controls shelf life.